Consistency between Causality Assessments Obtained With Various Scales and Their Agreement for Adverse Drug Events Reported in Pediatric Population

Abstract

Objective: The goal of this study was to examine correlation between various causality assessments scales and their agreement in reporting ADRs in children. Methods: All hospitalized pediatric patients were followed up for adverse drug reaction in a single pediatric unit for one year. We compared the WHO, Naranjo, CIOMS/RUCAM and French causality assessment scales in 36 identified ADRs in pediatric ward during 2012. The agreement between obtained causality assessments were analyzed by Cohen’s Kappa (K) statistical test. Results: In the 290 pediatric patients, 36 adverse drug reactions were noted. Prevalence of ADR was 10.3%. Maculopapular rash was most frequently observed ADR. Antimicrobials (56%) were the most commonly involved drug group in ADR and cephalosporin’s being the most frequent cause for ADR. RUCAM and French scale showed better agreement (K:0.067) with each other as compared to other scales. WHO and French scale showed least agreement (K:-0.026) with each other as compared to other scales. Naranjo’s scale showed poor agreement (K:0.014) with WHO scale and worse agreement (K:-0.016) with French scale. There was no correlation between RUCAM and Naranjo’s scale. Conclusion: Full agreement was not found between any of two scales of causality assessment. There was discrepancy seen between scalesdue to different definitions of causality criterias for assessing adverse drug reactions.This can influence the outcome of causality assessment significantly. Key words: ADR, Causality scales, Children, Correlation, Kappa.